Clinical Project Manager II

Updated: December 5, 2017
Job ID: 213443
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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The incumbent is responsible for providing support for ongoing research and program activities within the Clinical Directorate of the U.S. Military HIV Research Program (MHRP, www.hivresearch.org), specifically, the program under the International HIV Prevention and Treatment (IHPT)/PEPFAR group, under the guidance  of the Associate Director for Integration of Program Impact, Policy and Science (AD/PIPS). The incumbent will be primarily responsible for assisting program investigators with the design and implementation of HIV related research as part of MHRP participation in the implementation of the President’s Emergency Plan for AIDS Relief (PEPFAR). The incumbent will be responsible for overseeing ongoing research management activities, participate in research protocol development, implementation, analysis and publication activities, and may serve as an investigator for selected research projects in addition to working with country teams to support development and implementation of studies.

Responsibilities:

Under the guidance and oversight of the AD/PIPS, oversee the research management aspects of the operations research and evaluation portfolio for IHPT, including:

  1. Advising implementing partners and other agencies on WRAIR IRB submission process and timelines;
  2. Develop written guidance for suggested approach to interagency collaborative protocol development and IRB submission;
  3. Routinely liaise with the Clinical Operations Office (COO);
  4. Conduct an internal mapping and assessment of common pitfalls and bottlenecks to timely protocol development and submission, that can be used to inform strategies for resolution;
  5. Develop and implement systems to facilitate IHPT’s timely submission of new protocols and amendments based on findings from the mapping and assessment activity.
  6. Support annual strategic planning activities, including review of the: alignment of research portfolio with PEPFAR goals (currently prevention + 90-90-90), alignment of program and research portfolios, and strategic research direction.

 

  1. Program Evaluation – 25% FTE

Support ongoing evaluation activities, including:

  1. S/GAC and interagency evaluation work stream
  • Serve as a secondary point of contact on the PEPFAR Evaluation Short Term Task Team and execute related activities including reporting;
  • Support an internal review and mapping to identify where IHPT evaluation activities do (and potentially do not) align with PEPFAR’s ESoP 3.0 and established evaluation definitions;
  1. Basic Program Evaluation activities
  • Contribute to basic program evaluation (BPE) protocol development and revisions;
  • Actively serve as an investigator on BPEs, and contribute to BPE concept note development and execution, including conducting corresponding data analysis;
  1. Other operations and implementation research activities related to evaluation
  • Contribute to ongoing assessment of the links between program and research data, including strategizing about ways to leverage both for enhanced understanding of programmatic outcomes;
  • Serve as an IHPT evaluation subject matter expert (SME) in discussions in support of development of operations research or implementation science protocols designed to evaluate an intervention(s);
  • Actively participate on the AFRICOS Program Working Group, with opportunity to propose and contribute to AFRICOS data analysis in relation to roll out of program specific activities.

 

  1. Research Study Execution – 25% FTE

Contribute to the execution of research studies, including:

  1. Develop a tool for routine tracking and assessment of study monitoring needs, and contribute to evaluation of IHPT staffing capacities vs. the need to enlist COO member time for monitoring activities;
  2. Oversee the development Standard Operating Procedures, in conjunction with study Principle Investigators (PIs), to inform all aspects of study implementation;
  3. Develop training materials for SOP implementation and train study staff on SOPs;
  4. Travel to international research sites to assist with study implementation, monitoring, and closeout as needed.
  5. Conduct data cleaning, data analysis and interpretation activities;
  6. Participate in manuscript preparation and submission, including serving as an author where applicable.
  7. Develop a two year plan for IHPT dissemination of operations research and evaluation findings and activities, including: conference participation, in-country dissemination activities for each study, publications.

 

  1. Protocol and grant development – 10% FTE

In coordination with MHRP Investigators, clinical trial specialists, project managers, data specialists and statisticians, support ongoing protocol and future grant development efforts, including:

  1. Serve as a junior investigator on operational research studies, and other research protocols;
  2. Provide writing support for protocol and CRFs, performing literature reviews, drafting basic analytic plans;
  3. Serve as the focal point for convening and facilitating the coordination of concept note development and review by the Internal Scientific Review Committee (ISRC);
  4. Participate in budget preparation in collaboration with the Financial Office as required;
  5. Contribute to preparation of grant applications as required.

 

  1. Supervisory Duties – 10% FTE
    1. Supervise the day-to-day activities of Clinical Program Manager II and Research Associate on the Program Impact, Policy and Science (PIPS) team.
  2.  

OTHER DUTIES                                                                                                      5% OF TIME

  • Provide collaborative assistance to other program personnel and research scientists that require the incumbent's expertise;
  • Maintain a safe work environment by participating in personnel training;
  • Maintain appropriate trainings including CITI trainings as required to perform research related activities;
  • Complete other projects as needed.
  • Performs other duties as assigned

Required Knowledge, Skills, and Abilities

  • Knowledgeable in public health and clinical research procedures;
  • Demonstrated experience with:
    1. institutional review boards in the U.S. and in Africa 
    2. protocol development and writing, including literature reviews
    3. budget development and management
    4. quantitative research data, including data cleaning, statistical analysis to include regression analyses, and interpretation of findings, and the use of one or more statistical packages such as Stata, SPSS, or SAS
    5. manuscript preparation and submission
  • Demonstrated initiative, creativity and flexibility in problem solving, and the ability to work as part of a team;
  • Demonstrated capacity for fostering positive intercultural and interpersonal relations;
  • Demonstrated ability to work independently, be reliable, and meet multiple tight deadlines in a fast-paced environment;
  • Fluent in oral and written English with excellent communication skills, including writing ability;
  • Possesses minimum of 1-2 years supervisory experience.

Minimum Education/Training Requirements: Bachelor’s degree; Master of Public Health or related graduate degree preferred. Experience in research activities in resource constrained settings in Africa required.

Minimum Experience: 4-6 years of post-graduate clinical research or monitoring and evaluation experience; international work experience required; PEPFAR-related experience would be advantageous. Experience with protocol development and/or grant writing preferred.

Physical Capabilities: Incumbent will be based in Bethesda, MD and travel to research/field as required (approximately 30% of time on travel), sponsored by the MHRP to assist program personnel and liaise with on the ground DoD leadership.

Supervisory Responsibilities/Controls: Incumbent will work under the supervision of the Associate Director for Medical Affairs, and MHRP Director of Global Health Programs.

Work Environment:  Office/field environment; may require working evenings and weekends; may involve working with biohazardous materials.  Incumbent may be required to travel to field site locations in Africa on a regular basis.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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